Prolong® NexGen® 5952-40-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024208032), received between Nov 4, 2021 and Dec 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

67 other recalls cover devices cleared under the same FDA submission (K003910, K013991, K173057); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT PRESENTED INFECTION AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS LEADING TO A REVISION SURGERY. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED THEM WITH A SPACER. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Medical device site infection; Septic loosening

  MAUDE report 23694361 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 16750930 ↗
• MalfunctionNov 4, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE REPLACEMENT, THE SURGEON FAILED TO INSTALL THE ARTICULAR SURFACE. AFTER CLOSER INSPECTION, AN INTERNAL RIM FLAW WAS DETECTED. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY. A SECOND DEVICE WAS INSERTED WITHOUT ISSUE. ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003910, K013991, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1551-2012 · Feb 24, 2012 · Terminated
  00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw,
• Z-1559-2012 · Feb 24, 2012 · Terminated
  00-5970-020-12, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 12 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular S
• Z-1570-2012 · Feb 24, 2012 · Terminated
  00-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Wa
• Z-1596-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Steri
• Z-1576-2012 · Feb 24, 2012 · Terminated
  00-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, In
• Z-1556-2012 · Feb 24, 2012 · Terminated
  90-5952-020-20, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 20mm Height; St
• Z-1592-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Steril
• Z-1591-2012 · Feb 24, 2012 · Terminated
  REF 00-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9 mm Height , Steril
• Z-1589-2012 · Feb 24, 2012 · Terminated
  REF 90-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow/A-E 17 mm Height , Sterile
• Z-1561-2012 · Feb 24, 2012 · Terminated
  00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 17 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Kne
• Z-1588-2012 · Feb 24, 2012 · Terminated
  REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17mm Height , Steril
• Z-1569-2012 · Feb 24, 2012 · Terminated
  00-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9mm Height , ( 5.5MM under the Condyles) Ste
• Z-1553-2012 · Feb 24, 2012 · Terminated
  90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Steri

…and 52 more.